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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K132048
Device Name BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
Applicant
Molnlycke Health Care Us, LLC
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Applicant Contact CURTIS D TRUESDALE
Correspondent
Molnlycke Health Care Us, LLC
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Correspondent Contact CURTIS D TRUESDALE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received07/02/2013
Decision Date 11/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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